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New treatment option for Heart Failure With Preserved Ejection Fraction
Official title Exercise Lower-body Negative Pressure in Heart Failure With Preserved Ejection Fraction
ClinicalTrials.gov ID: NCT05582044
What this study is testing
- What it's testing
- The heart is a pump that must both fill and empty effectively to move blood; if it cannot move enough, heart failure may ensue. Approximately half of all adults living with heart failure have a form where the heart stiffens, which impairs its ability to fill.
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 40 and older. Healthy volunteers may be eligible.
You may be able to join if
- for the HFpEF Group:
- Adults with a clinical diagnosis of HFpEF (LV ejection fraction ≥50%) measured in the year prior to Visit 1 (and confirmed at Visit 1), who are New...
- Symptom(s) of heart failure requiring treatment within the year prior to Visit 1
- NT-proBNP \>50 pmol/L (sinus rhythm) or \>150 pmol/L (atrial fibrillation in year prior)
- Diastolic dysfunction based on at least one of the following echocardiographic findings:
You likely can't join if
- for the HFpEF Group:
- Any prior measurement demonstrated LV ejection fraction ≤40%
- Primary pulmonary, metabolic, renal, hepatic, neuromuscular, or malignant disease
- Primary pulmonary vascular, complex congenital, or \> mild valvular heart disease
- Documented infiltrative cardiomyopathy
- Documented valvular or coronary disease requiring intervention
See the full eligibility criteria
- for the HFpEF Group:
- Adults with a clinical diagnosis of HFpEF (LV ejection fraction ≥50%) measured in the year prior to Visit 1 (and confirmed at Visit 1), who are New York Heart Association Functional Class II-III (mild-moderate...
- Symptom(s) of heart failure requiring treatment within the year prior to Visit 1
- NT-proBNP \>50 pmol/L (sinus rhythm) or \>150 pmol/L (atrial fibrillation in year prior)
- Diastolic dysfunction based on at least one of the following echocardiographic findings:
- Left atrial enlargement (diameter \>4 cm or volume index \>28 mL/m2); or
- e' \<10 cm/s (lateral) or \<8 cm/s (septal), or
- E/e' \>10 (lateral), or \>15 (septal) for the Healthy Control Group: \- Healthy sedentary or recreationally active adults from the community
- for the HFpEF Group:
- Any prior measurement demonstrated LV ejection fraction ≤40%
- Primary pulmonary, metabolic, renal, hepatic, neuromuscular, or malignant disease
- Primary pulmonary vascular, complex congenital, or \> mild valvular heart disease
- Documented infiltrative cardiomyopathy
- Documented valvular or coronary disease requiring intervention
- Myocarditis, pericardial effusion, acute coronary syndrome, or revascularization in the last 3 months
- Resting seated systolic blood pressure \>160 mmHg or \<100 mmHg
- Jugular venous pressure \>12 cm
- Inferior vena cava \>2 cm with no inspiratory collapse, or severe right ventricular dysfunction by echo
- Ambulatory supplemental oxygen
- Current or recent participation in \>150 min. per week of moderate intensity exercise
- Current or recent (within the past 6 months) smoking
- Body mass index \>35 kg/m2
- Contraindication to exercise or otherwise unable to perform cycle ergometry
- Poor echocardiographic imaging windows Exclusion Criteria for the Healthy Control Group
- Current or recent participation in \>150 min. per week of moderate intensity exercise
- History of any cardiovascular condition or cardioactive drug use
- History of any respiratory condition including asthma
- History of any metabolic condition including diabetes
- Non-sinus rhythm
- Echocardiographic evidence of significant left ventricular hypertrophy, valvular abnormalities, left ventricular ejection fraction \<50%, or diastolic dysfunction as described in HFpEF inclusion criteria.
- Seated blood pressure ≥140/90 mmHg
- Any other chronic systemic illness
- Current or recent (within the past 6 months) smoking
- Body mass index \>35 kg/m2
- Contraindication to exercise or otherwise unable to perform cycle ergometry
- Poor echocardiographic imaging windows
The study team makes the final eligibility decision.
Where it's taking place
- Kelowna, British Columbia, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 40 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Kelowna, British Columbia, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.